1. BOGUS DRUGS
Unauthorised drugs or drugs which do not meet standards or those which do not
adhere to a standard allopathic medical formulary are found in abundance in the
local market. Most often, devoid of a generic identity, these so called drugs are
invading the market with massive advertising campaigns, luring the consumer
who will be at the receiving end, ignorant of the fact that the high cost of a drug
or the quantity administered do not stand as markers of a ‘speedy recovery’ or
the competency of the medical practitioner. What are the motives behind this
trend of promoting such unauthorised drugs? What are the rights of the patients
in this regard and most importantly, what are the obligations of the Medical
fraternity regarding this national issue of concern? The Nation strived to find
answers…
By Randima Attygalle
For a certain drug to be recognised as an accepted preparation, it should
necessarily undergo ‘clinical trials’ under the supervision of
internationally accepted forums. Needless to say that, despite
international and home-grown policies regulating the quality of drugs
entering the market, ‘unauthorised’ drugs, or those which do not
subscribe to allopathic medical standards have been in existence for a
considerable period of time, although the issue has come under the
spotlight as of late. “Very often, these drugs which are found in the local
market, come under brand names only free of a generic name, which
give a clue that the preparation in issue is not an authorised drug or a
drug approved by international forums of quality assurance,” explained
Dr. Shantha Hettiarachchi, Co-ordinator- Mass Communication Publicity Unit, Health
Education Bureau, Ministry of Healthcare & Nutrition.
Predominantly imported from India, along with a considerable percentage from the
West as well, majority of these so called drugs are recommended for lowering blood

2. pressure-hypertension, blood sugar and cholesterol. Among this array of preparations
is a notable brand name prescribed for post-menopause females, according to Dr.
Hettiarachchi. “This brand is increasingly being prescribed by certain local
practitioners as a substitute for Hormone Replacement Therapy, which can have
adverse effects on the user,” he added. Dr. Hettiarachchi’s campaign of addressing
this concern over a considerable period of time has made shocking revelations, such
as the discovery of clinical prescriptions containing 10 to 15 drugs or even more,
which are ‘unknown’ to the standard medical practice. “It is the basic knowledge of
an authorised physician that certain ailments can be cured or managed with one or two
drugs and, at times, with no drugs at all. My personal investigations have revealed
that, even in such instances, certain physicians have prescribed preparations
containing no literature on their generic value and sometimes, these prescriptions are
as lengthy as a standard A4 paper,” elaborated Dr. Hettiarachchi.
Vague markers
What are the markers to determine that a drug in issue is an authorised or a quality-
assured one? According to Dr. Hettiarachchi, they are not forthright ones
unfortunately. “This is the grave issue. Patients have faith in what a clinician
prescribes, and the mentality of the average patient is that more drugs one takes, better
the doctor is or more expeditious the recovery is. This is not so. As clinicians we are
aware of what the accepted drugs in the market are, by perusing and being updated
with pharmacological texts and other international medical publications. Most of the
drugs identified as unauthorised are oblivious to these reputed publications, although
freely available in the market, which give the physician a clue that there is a doubt
cast on the particular drug in issue,” explained Dr. Hettiarachchi, adding that, on the
part of the patient, identification is a challenging task. The basic markers would be the
absence of literature pertaining to generic element, and lengthy prescriptions with
exceptional amount of drugs.
Registration procedure
Amending the existing legislation, pertaining to the importation, distribution and sale
of drugs, and implementing timely legislation to the same is of paramount importance,
in the light of present affairs. To delve into the pressing policy needs, The Nation also
spoke to Chairman- State Pharmaceuticals Corporation and State Pharmaceuticals
Manufacturing Corporation, Ministry of Health, Prof. S.D. Jayaratne. Shedding light
upon the registration procedure of imported drugs, Prof. Jayaratne cited, “once a
particular drug goes through the five phases of a clinical trial and having obtained
what is known as a Free Sales Certificate, which is a passport for the sale of a drug
within the country of manufacture and importation, our local drug registration
authority, National Drug Quality Assurance Laboratory (NDQAL) stipulates a
mandatory regulation of registration of drugs on the importer. A very strict procedure

3. has to be followed by an importer, in order to meet the necessary requirements laid
down by NDQAL, and to assure the authenticity of the importer’s company to be
qualified as an importer of drugs.”
Mechanism drawbacks
Regulations related to the Tender Procedure require the most economical drugs to be
imported into the country, making India the most potential market in this context.
“India is, no doubt, a hub for the importation of drugs, and the competition among
Indian drug manufacturers is getting worse each day, to qualify as the most
economical source. Despite the fact that there are very reputed and authentic Indian
drug manufacturing companies, there are oddities at the same time, the authenticity of
which the local authorities cannot determine on the face value per se, because there
are channels of obtaining bogus registration documents,” elaborated Prof. Jayaratne,
adding that, the absence of Post Marketing Surveillance Strategy in Sri Lanka has
made the screening process a challenging endeavour. “Both NDQAL and SPC Quality
Assurance Laboratory are entrusted with testing the samples of imported drugs-
NDQAL responsible for drugs imported to the Ministry of Health and the latter for the
drugs imported for distribution via Osu Sala. The issue arises when a disparity occurs
between the quality of the sample produced for testing and the end product which is
eventually imported,” he explained further.
New legislature
The practical solution to assure the superior quality of the drugs imported, according
to Prof. Jayaratne, is to carry out random sample checking, the cost of which should
be borne by the supplier or the importer. Current legislative provisions do not
empower NDQAL to carry out random sample checking and screening of each batch
of imported drugs, thus implementation of new legislature is a dire need. “Random
screening is an exorbitant procedure which a government authority alone cannot bear.
Thus a practical solution such as a government-private collaboration where the
importer is made to bear the cost of the procedure should be implemented,” cited Prof.
Jayaratne who opines that such a mechanism will make the importer liable for quality
failure, accompanied by penalties which will naturally keep a check on the quality of
drugs imported.
Certain loopholes in existing legislative enactments such as the Cosmetics, Devices &
Drugs Act, No 27 of 1980, also require serious amendments. For instance, the
definition of the word ‘drug’ excludes ayurvedic and homoeopathic drugs and
medicine, a provision which can be exploited by unscrupulous suppliers who can
resort to the importation of herbal concoctions, which can be produced as ‘drug-like’
substances eventually. The absence of clauses related to ‘vitamin and other health
supplements’ can also be perceived as a serious lacuna in the Act. Thus, the
implementation of the National Drugs Policy is a need of the hour. “National Drugs

4. Policy, formulated by various stakeholders concerned with the Health sector of the
country, needs urgent implementation, in order to streamline the importation,
distribution and sale of drugs,” explained Prof. Jayaratne, who further said that the
policy will largely address the allegations of corruption attached to the present
registration process, which involves many red tapes.
Patients’ rights
The bitter truth behind the unauthorised drugs is threefold- to attract patients who
harbour the misconception that more drugs do more good, to satisfy the agendas of
pharmaceutical companies and to earn quick money. In such a backdrop, where does
the patient stand? What are his/her rights? What are the obligations of the physician
towards his/her patients? “Patients should be well aware of the fact that, what cures an
illness is the right drug, irrespective of the price. A drug more expensive is not
necessarily the more suitable drug, and neither does it give better results. The number
of drugs prescribed does not have any co-relation to the disease’s severity, time taken
for recovery, or the competency of the doctor. Most of the time, more the number of
drugs, more the side effects. It’s a right of the patient to ask the doctor why he or she
is prescribed a certain drug and may be, an alternative at times,” explained President-
Government Medical Association, Castle Street Hospital Women’s Branch, Dr
Sankalpa Marasinghe.
Streamlining regulations
Elaborating on the need to implement a proper regulatory method of controlling the
quality and price of drugs in the market, Dr. Marasinghe also stressed on the
importance of identifying clear demarcations of branches of medicine to which a drug
belongs. “There should be a clear demarcation to which branch of medicine a certain
drug belongs to, such as allopathic, ayurvedic etc. Those who are registered under
allopathic medicine, for instance, should prescribe only those drugs which come under
and registered as allopathic medicine. For the purpose of using new drugs (other than
those under allopathic medicine), a clear guideline should be provided, so that the
patient is also aware that the treatment is on a trial basis,” cited Dr. Marasinghe, who
further said that enforcing laws blindly to restrict the autonomy of doctors will only
cause harm to the advancement of medicine and hinder the clinicians capacity to
deliver the best possible treatment. “Most drugs we use today have been discovered
by chance or accident. This is as a result of doctors using various compounds and
known drugs to treat illnesses. However, this is not by any means suggesting that
drugs are chosen for treatment in an ad hoc manner. Clinicians use their core
knowledge, experience and rational thinking to decide which drug to use, even as an
experiment. A classic example is the drug which was used to treat angina, which was
eventually detected to be causing erection in men. It later became known the world
over as ‘Viagra’, the wonder drug of the 21st century, which cured male impotence.

5. The same drug was found to be beneficial in treating pulmonary hypertension in
neonates. Now it has become a vital drug at Intensive Care Units for newborns,”
elaborated he. In conclusion, Dr. Marasinghe also added that alternative brands of a
drug in the market should be limited, whilst a mechanism for proper assessment and
maintenance of their quality be initiated, for which purpose the implementation of the
National Drug Policy should be expedited.